Drugs / Oxalobacter formigenes
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02000219 | May 2014 → Jan 2020 | primary hyperoxaluria | OxThera | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT01037231 | Dec 2009 → Jan 2011 | primary hyperoxaluria | OxThera | Completed | No outcome recorded |
| Phase 2/3 | NCT00638703 | Oct 2007 → Sep 2008 | primary hyperoxaluria | OxThera | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2021-06-11 | OxThera | Results OxThera reports results from Phase 3 ePHex study with Oxabact in primary hyperoxaluria patients with maintained kidney function cision.com ↗
OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), announces completion of its pivotal Phase 3 study and reports top line results. |
| 2021-02-19 | OxThera | Results Plasma oxalate and kidney function are correlated in patients with primary hyperoxaluria with maintained kidney function – Data from three placebo‑controlled studies published cision.com ↗
An inverse correlation between eGFR and Pox was observed (p<0.05) in each of the three studies with correlation coefficients of -0.44, -0.55 and-0.51, respectively. |
| 2020-03-12 | OxThera | Results Oxabact[®] treatment combined with intensive dialysis lowers plasma oxalate and halts disease progression in a patient with severe infantile oxalosis cision.com ↗
The treatment reduced plasma oxalate levels and stabilized systemic oxalosis. |
| 2019-08-23 | OxThera | Regulatory OxThera receives positive decision from EMA on Paediatric Investigational Plan (PIP) for treatment of primary hyperoxaluria with Oxalobacter formigenes cision.com ↗
OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), today announced that, based on a positive opinion from the Paediatric Committee (PDCO), the EMA has agreed to the proposed PIP for Oxalobacter formig enes in the treatment of primary hyperoxaluria. |
| 2019-06-27 | OxThera | Results OxThera presents continuous strong data from an interim analysis of its Phase 2 study with Oxabact in Primary Hyperoxaluria cision.com ↗
The two-year interim analysis shows continuous reductions in Pox (level of oxalate in the blood plasma) of - 40% (-67 µmol/L) compared with baseline. |
| 2018-10-31 | OxThera | Results OxThera presents encouraging 52-week efficacy and safety data for Oxabact® in Primary Hyperoxaluria type 1 (PH1) patients with ESRD cision.com ↗
OxThera AB, a Stockholm-based privately-held biopharmaceutical company and leader in the field of microbiome derived biotherapeutics, today announced a poster presentation showing encouraging Oxabact® efficacy and safety data from the longterm study OC5-OL-01, at the Annual Meeting of the American Society of Nephrology Kidney Week 2018 in San Diego. |
All press releases naming this drug 6 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Oxalobacter formigenes | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01037231 ↗ |
| Modality | Other / unclassified | “Biological: Oxalobacter formigenes” NCT00638703 ↗ |